E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain, after orthopaedic surgery. |
Postoperative pain after major shoulder surgery Postoperative pain after total knee arthroplasty Postoperative pain after orthopaedic surgery to the foot or ankle |
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E.1.1.1 | Medical condition in easily understood language |
Pain after orthopaedic surgery. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029173 |
E.1.2 | Term | Nerve block |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this trial is to investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing orthopaedic surgery. This is exemplified in three sub-trials on different populations: 1: Patients undergoing major shoulder surgery 2: Patients undergoing foot or ankle surgery 3: Patients undergoing major knee surgery
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E.2.2 | Secondary objectives of the trial |
1: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major shoulder surgery.
2: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing surgery of the foot or ankle.
3: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major knee surgery. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudy one: Title: Catheter based analgesic treatment after major shoulder surgery: Low dose automated periodic infusions compared to continuous infusion. Date: 2017.06.28 Version 1.0 Objective: To compare a low dose AIBR with a high dose CPNB for catheter-based brachial plexus block, as primary pain therapy for patients undergoing major shoulder surgery.
Substudy two: Title: Comparison of a low-dose automated, periodic infusion with conventional continuous infusion in catheter-based sciatic nerve blocks. Date: 2017.07.12 Version: 1.0 Objective: to investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based sciatic nerve block treatment for patients undergoing lower limb surgery to the foot or ankle.
Substudy three: Title: Comparison of a low dose automated, periodic infusion with conventional continuous infusion in catheter-based adductor canal blocks. Date: 2017.07.06 Version: 1.0 Objective: to investigate whether a low-dose automated period infusion regimen can produce a similar analgesic effect compared to a conventional, high dose continuous infusion regimen in catheter-based adductor canal block treatment for patients undergoing total knee arthroplasty. |
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E.3 | Principal inclusion criteria |
Substudy one: 1. ≥18 years of age 2. Scheduled for elective shoulder arthroplasty, rotator cuff repair, or Bankart operation 3. ASA classification24 ≤ III 4. Agreement to the trial protocol
Substudy two: 1) Age ≥ 18 years 2) American Society of Anesthesiologists Classification I-III 3) Normal cognitive function in order to sign written, informed consent and to understand trial protocol 4) Agreement to the trial protocol, including the randomized manner
Substudy three: 1) Age ≥ 18 years 2) American Society of Anesthesiologists Classification I-III 3) Normal cognitive function in order to sign written, informed consent and to understand trial protocol 4) Agreement to the trial protocol, including the randomized manner |
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E.4 | Principal exclusion criteria |
Substudy one: 1. Body weight ≤ 50 kg 2. Allergy to local anaesthetics 3. Mental or cognitive disease that impede compliance 4. Contraindication of interscalene brachial plexus nerve block (i.e. pneumothorax, severe pulmonary disease) 5. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion. 6. Pregnancy or breastfeeding
Substudy two and three: 1) Allergy to LA 2) Infection in or near insertion site of the peripheral nerve catheter 3) Habitual use of opioids 4) Pregnancy or breastfeeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
AUC for pain during 72 h postoperatively, measured with a numerical rating pain score (NRPS)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the first 72 hours post-operatively, we will gather information on each participants level of pain. At the end of the trial the pain scores will be translated into the AUC value. |
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E.5.2 | Secondary end point(s) |
Substudy one and two: • Opioid consumption during 72 h postoperatively • Volume of PCA administered LA during 72 h postoperatively
Substudy three: 1. Opioid consumption during 72 h postoperatively 2. Volume of PCA administered LA during 72 h postoperatively 3. AUC for pain (NRPS) during active knee flexion during 72 h postoperatively.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Opioid consumption and volume of LA is evaluated after the 72 hour period.
AUC for pain during active knee flexion is calculated from values gathered during the 72 hour period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Continuous infusion of LA through a nerve catheter |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when 90 patients have completed the intervention in each of the 3 sub-divided trials. We plan to have completed the trial (last visit, last patient) 1st of May 2018. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |